Idelvion

Pronunciation: eye-delve-vee-on
Generic name: human coagulation factor ix recombinant, albumin fusion protein
Dosage form: powder for intravenous injection
Drug class: Miscellaneous coagulation modifiers

Medically reviewed by Carmen Pope, BPharm. Last updated on Apr 18, 2024.

What is Idelvion?

Idelvion (coagulation factor ix recombinant, albumin fusion protein) is a long-acting, injectable, human blood coagulation ix factor that may be used to manage active bleeding, bleeding during surgery, and to reduce the frequency of bleeding episodes in adults and children with hemophilia B.

Hemophilia B (also called congenital Factor ix deficiency or Christmas disease) is an inherited bleeding disorder characterized by deficient or defective factor ix, that prevents blood from clotting normally. Idelvion works by temporarily replacing the missing coagulation Factor ix needed for effective blood clotting (hemostasis). It is made up of a genetically fused recombinant coagulation Factor ix and recombinant albumin. Fusion with this recombinant albumin extends the length of time it lasts for in the body which means it can be given less frequently than other factor products.

Idelvion was FDA approved on March 4, 2016.

Idelvion side effects

Idelvion can cause serious side effects (see warnings below).

The most common side effects of Idelvion affecting 1% or more people receiving it are headache and dizziness.

These are not the only side effects possible with Idelvion. To learn more, talk to your healthcare provider or pharmacist. Tell your healthcare provider about any side effect that bothers you or does not go away. You may report side effects to the FDA at 1-800-FDA-1088.

Warnings and serious effects

Do not receive Idelvion if you:

• have had life-threatening hypersensitivity reactions to Idelvion, human coagulation factor ix recombinant, albumin fusion protein, or any of the inactive ingredients in the vial.
• are allergic to hamster proteins.

Allergic and hypersensitivity reactions have been reported with Idelvion. Call your healthcare provider right away and stop treatment if you get a rash or hives, itching, tightness of the chest or throat, difficulty breathing, light-headedness, dizziness, nausea, or a decrease in blood pressure.

Your body can make antibodies, called inhibitors, against Factor ix, which may stop Idelvion from working properly. Your healthcare provider may need to test your blood for inhibitors from time to time.

Idelvion may increase the risk of forming abnormal blood clots in your body, especially if you have risk factors for developing blood clots. Call your healthcare provider if you have chest pain, difficulty breathing, leg tenderness, or swelling.

Idelvion cost

The cost of prescription drugs varies depending on your insurance plan and which pharmacy you use. Refer to our price guide page for more information about Idelvion's cost.

You may also be eligible for an Idelvion coupon or Idelvion copay card. Ask your doctor or pharmacist if you qualify.

Before taking

Before receiving Idelvion, you should tell your healthcare provider if you:

• have or had any medical problems
• take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal remedies
• have had an allergic reaction to any Factor ix product before using Idelvion
• have any allergies, including allergies to hamster proteins
• have been told that you have inhibitors to Factor ix (because Idelvion may not work for you)
• are pregnant or planning to become pregnant
• are breastfeeding.

Pregnancy

Idelvion may harm your unborn baby. Talk to your healthcare provider about the risks involved with receiving Idelvion if you are pregnant.

Breastfeeding

It is not known if Idelvion passes into your milk and if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with Idelvion.

How is Idelvion administered?

Idelvion is administered by an intravenous (into a vein) infusion, directly into the bloodstream. It is usually administered by a healthcare provider initially, but people can be taught how to self-administer it or a caregiver taught how to administer it to a person with hemophilia B.

• Do not attempt to administer Idelvion yourself unless you have been shown how to do so by a healthcare provider.
• Follow the step-by-step instructions provided in the product information.
• Idelvion needs to be diluted before use. Once diluted, it should be administered immediately or within 4 hours of mixing.

Your healthcare provider will tell you how much Idelvion to administer based on your weight, the severity of your hemophilia B, and where you are bleeding.

You may need to have blood tests done after administering Idelvion to be sure that your blood level of Factor ix is high enough to clot your blood.

Call your healthcare provider right away if your bleeding does not stop after administering Idelvion.

Idelvion may be used:

• To control and prevent bleeding episodes
• During surgery to manage bleeding
• To reduce the number of bleeding episodes when used regularly (prophylaxis).

The frequency of administration depends on what Idelvion is being used to treat, but it is usually given every 7 to 14 days to prevent and control bleeding episodes.

Do not use Idelvion for a condition for which it is not prescribed or share it with other people, even if they have the same symptoms that you have.

Idelvion dosage strengths

Idelvion intravenous kit comes in five different dosage strengths which are printed on the carton and vial label:

• 250 IU (orange)
• 500 IU (blue)
• 1000 IU (green)
• 2000 IU (purple)
• 3500 IU (yellow).

Always check the Idelvion dosage strength printed on the label to make sure you are using the strength prescribed by your healthcare provider. Your healthcare provider will tell you your Idelvion dosage based on your weight, the severity of your hemophilia B, and where you are bleeding.

Related/similar drugs

BeneFix, Beqvez, Alprolix, Hemgenix, NovoSeven RT, Sevenfact

What happens if I miss a dose?

If you miss a dose, administer that dose as soon as possible and then resume your regular dosing schedule. Call your healthcare provider for more information.

What happens if I overdose?

Call your healthcare provider or call the Poison Help line at 1-800-222-1222.

What other drugs will affect Idelvion?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Idelvion may affect the way other medicines work. Especially tell your healthcare provider if you take other medications that:

• affect the way your blood clots, such as carfilzomib
• affect other coagulation factors, such as efgartigimod alfa or rozanolixizumab.

Know the medicines you take and the vaccines you receive. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. See the prescribing information for a full list of interactions.

Storage

Store the unmixed vial of Idelvion in its original carton to protect it from light. It can be stored in the refrigerator or at room temperature at 36-77°F (2-25°C). Do not freeze.

Do not use it after the expiration date printed on the label.

Once the dry product has been mixed with the diluent (reconstituted) it must be used within 4 hours. Do not refrigerate, keep at room temperature.

Discard any Idelvion left in the vial at the end of your infusion.

Idelvion ingredients

Active: recombinant albumin fusion protein human coagulation Factor ix

Inactive: Water for Injection, sodium citrate, polysorbate 80, mannitol, and sucrose.

Contains no preservatives.

Available in the following unit strengths: 250, 500, 1000, 2000, or 3500 IU

Manufacturer

CSL Behring GmbH.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer